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Over the past 25 years I have had the unique opportunity to talk directly with many of the professionals and instruc

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

tors who use Overhead Projectors as an integral part of their profession. Through these interactions I have accumula

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ed notes and information that has inspired me to write these articles that pertain to some of the most common proble

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

s experienced by owners of today's and yesterday's Overhead Projectors. This is the sixth article in a series of art

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

cles that will be written from a professional Electronics Technicians point of view in regards to some of today's mo

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

t common Overhead Projector problems. This article will cover the difference between a thermal fuse and a thermal sw

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

tch.

Let's start with the thermal fuse. In many cases the manufacturer will place a thermal fuse in the electrical

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ircuit of your Overhead Projector to protect the projector from damage due to excessive heat.

How the thermal fuses

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

works is rather simple in nature. The fuse is rated a particular temperature rating pre determined by the manufactur

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

r. If for some reason the cooling system in your overhead projector fails the thermal fuse will open once it has rea

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

hed the pre-determined temperature, shutting the power off to the projection lamp. Once the thermal fuse has done i

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

s job, it will need to be replaced, as it can not be reset.

I am often asked if this thermal fuse can be bypassed i

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

stead of being replaced. Yes it can, but our advice is not to by-pass this important safety feature of your Overhead

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

Projector. Saving a few dollars now could cost you a lot more in the future without this important safety device.

T

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ermal switches perform a different function in your Overhead Projector. The thermal switch we refer to here is used

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

o control the cooling system of the Overhead Projector. The thermal switch remains in an open state (no current flow

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

until it reaches a pre determined temperature, at which time the thermal switch closes and makes an electrical circ

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

it allowing the cooling fan to operate. When the Overhead Projector is turned off the fan will continue to run until

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

the unit cools off enough to let the thermal switch open back up turning the fan off.

Both of these electronic comp

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

nents are an integral part of your Overhead Projector and should be replaced by a professional Electronic Technician

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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